Content about Food and Drug Administration

March 14, 2014

Legislation introduced to unclog the backlog of sunscreen ingredients and streamline the review process for faster public access has garnered the accolades of the Public Access to SunScreen Coalition.

March 13, 2014

Using azithromycin and levofloxacin increases the risk of cardiac arrhythmia and death, according to a study of U.S. veterans.

March 12, 2014

Upsher-Smith has received approval from the Food and Drug Administration for Qudexy XR (topiramate) extended-release capsules, a once-daily, broad-spectrum antiepileptic drug specifically engineered to deliver a smooth pharmacokinetic profile.

March 12, 2014

Walmart has joined almost two-dozen organizations from across the healthcare supply chain in a letter calling on the Food and Drug Administration to consider the public health impact of its Proposed Rule on pharmaceutical labeling.

March 10, 2014

Although the United States is still waiting for final practical guidelines from the Food and Drug Administration about the launch of biosimilars and the standards required to meet the threshold of interchangeability, the rest of the world seems to be barreling forward with the development and launch of these important medicines.

March 10, 2014

Two Rx-to-OTC switches in the past year may serve as a harbinger of what the Food and Drug Administration will consider “switch” worthy.

March 10, 2014

A Maryland bill that is intended to help pharmacies in managing inventories and avoid potential drug shortages could create hardships for distributors, according to an FDA law blog.

March 7, 2014

It's finally happening. Pfizer has placed the ball at the line of scrimmage. And based on the X's and O's to come out of its Lipitor OTC actual-use study, Pfizer will be making its run with its eye on the ultimate prize — a successful Rx-to-OTC switch of a statin.

Only this time, the Food and Drug Administration may not be as quick to sack Pfizer's switch attempt. With the advances and pervasion of health technology in the self-care space by way of smartphones and tablets; with the evolution of the pharmacist as a healthcare professional able to practice at the top of their license; and with the adoption of diagnostic tests like a cholesterol panel that can be physically administered in the pharmacy, consumers may finally get it right when self-selecting a statin.

Because it's the consumer actual-use studies that have scuttled just about every statin switch attempt in the past. In the last switch of Mevacor, FDA advisory panelists determined the statin was safe enough for the self-care space. And it was effective. It's just that the consumers who would be right for an OTC statin didn't appropriately self-select. And if they can't appropriately self-select, what's the point, really?

March 7, 2014

A study published online Friday shows that the omega-3 fatty acids EPA and DHA — commonly found in fatty fish and fish oil supplements — are as effective, if not more effective, in lowering blood pressure as some of the commonly recommended lifestyle changes like increasing physical activity and restricting alcohol and sodium intake.

March 6, 2014

In anticipation of the March 13 deadline for comments on the FDA's proposed rule on prescription generic drug labeling, 21 health industry groups submitted a new letter to the agency on Thursday, raising concerns about the proposed regulation.

March 6, 2014

Lupin on Thursday announced that it received final approval from the Food and Drug Administration for both its doxycycline capsules and its ciprofloxacin for oral suspension.

March 6, 2014

The administration is seeking $4.7 billion for the Food and Drug Administration, representing a 6.8% increase, according to a report published Tuesday by the Washington Post.

March 4, 2014

Church & Dwight on Tuesday announced that the Food and Drug Administration has cleared the First Response Gold Digital Pregnancy Test to determine if a woman is pregnant up to six days before her missed period and with more than 99% accuracy from the day of her expected period.

March 3, 2014

AstraZeneca received approval from the Food and Drug Administration for its Bydureon pen (exenatide extended-release for injectable suspension) 2-mg, which is to be used as an addition to diet and exercise to improve glycemic control in adults with Type 2 diabetes.

March 3, 2014

The Food and Drug Administration last week ruled that generic equivalents to Teva Pharmaceutical's Plan B emergency contraceptive can be sold alongside Plan B without any behind-the-counter merchandising restrictions or a requirement to verify the age of the purchaser in a letter to the interested parties.

March 3, 2014

The Generic Pharmaceutical Association on Friday hosted a Congressional briefing highlighting the economic impact the Food and Drug Administration’s proposed rule on prescription labeling that would allow for label changes without prior FDA approval.

February 28, 2014

The Consumer Healthcare Products Association earlier this week voiced support for keeping over-the-counter bronchodilators in the OTC Monograph during a recent meeting of the Food and Drug Administration’s Nonprescription Drugs Advisory Committee.

February 28, 2014

The Council for Responsible Nutrition on Friday welcomed news of the U.S. Food and Drug Administration’s proposed rule, “Food Labeling: Revision of the Nutrition and Supplement Facts Labels.”

February 28, 2014

Lupin announced that it received approval from the Food and Drug Administration for rifabutin capsules USP, 150-mg, a generic version of Pharmacia and Upjohn Company's Mycobutin capsules.

February 28, 2014

Verizon’s Converged Health Management, a remote patient-monitoring medical platform designed to help clinicians and patients manage patients’ health in between doctor visits, recently received Food and Drug Administration 510(k) clearance to run on the iOS mobile operating system, Verizon announced Tuesday.

February 27, 2014

The Food and Drug Administration on Thursday proposed to update the Nutrition Facts label for packaged foods to reflect the latest scientific information, including the link between diet and such chronic diseases as obesity and heart disease.

February 27, 2014

LED Technologies announced has formed an alliance with Kathy Ireland Worldwide to develop reVive Light Therapy skin care devices for anti-aging; uneven skin tone and hyperpigmantation; acne; and skin healing.

February 26, 2014

A pair of Food and Drug Administration advisory committees on Tuesday voted against the over-the-counter sale of Armstrong Pharmaceuticals' Primatene HFA, an epinephrine inhalation aerosol indicated for the temporary relief of mild symptoms of intermittent asthma for people ages 12 years or older.

February 25, 2014

The Food and Drug Administration has approved Myalept (metreleptin for injection) to treat complications of leptin deficiency in patients with congenital generalized or acquired generalized lipodystrophy, a condition associated with a lack of fat tissue.

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